Bill Name: House Bill 4036 (HB 4036)

Primary Sponsor: Rep. Michele Peña

Status: 02/11/2026 Second reading: assigned to House International Trade and Rules Committees withdrawn from Health and Human Services Committee

AmSpa’s Take: Compounding has been a hot button issue recently as well. This bill appears to be part of a national effort to regulate GLP-1 compounding.

Analysis: Currently in Arizona, as in most states, compounding rules are primarily directed at regulating the practice of pharmacies. These cover the practice generally. If passed, HB 4036 would create special requirements for compounding pharmacies and practitioners when compounding medicines containing Glucagon-like peptide-1s (GLP-1) receptor agonists such as semaglutide and tirzepatide.

HB 4036 would prohibit any person or entity to sell, transfer or distribute compounded GLP-1 medication unless the compounder complies with all of the requirements of this bill. 

These requirements include that the compounder: 

1. Use a bulk drug substance that has a monograph, is part of a U.S. Food and Drug Administration (FDA) approved drug or appears on an FDA bulk drug substance list;
2. If the FDA approved drug labeling specifies a process for manufacturing, that the bulk drug substance followed that practice;
3. The substance is pharmaceutical grade;
4. The substance has a certificate of analysis;
5. Conducts and documents quality control testing of the bulk drug substance;
6. Conducts and documents quality control testing of the finished drug product in batches both before release and at expiry;
7. Obtains proof that the bulk drug substance was manufactured in an establishment that is registered with the FDA and has undergone an inspection in the last 2 years and is not subject to an FDA import alert; and
8. Complies with the Federal Food, Drug, and Cosmetic Act.

Bulk drug substance manufacturers and wholesalers would be prohibited from selling bulk drug substances unless they provide written verification that the substance is pharmaceutical grade and meets the sourcing requirements and provide documentation of the quality control testing and certificate of analysis. All records must be maintained for at least 2 years by anyone selling, transferring or distributing the compounded drugs. The Arizona State Board of Pharmacy is also authorized to inspect anyone involved with compounding, selling, or distribution for compliance with these provisions. Violations can result in fines of $1,000 per dose and suspension or revocation of professional license or permit.

HB 4036 also requires that all advertisements of GLP-1 medications must be truthful and not misleading. In this case, this includes any unsupported claims about the product. Advertisements are also misleading unless they include all of the following:  

• Disclosure of potential side effects, adverse reactions, contraindications, precautions, and warnings related to the active ingredients in the compounded medication, including any identified through clinical trials, research, or other appropriate sources.  
• A summary of specific risk information from the label of any FDA-approved drug when the compounded medication contains an active ingredient found in such an approved drug.  
• A clear and noticeable statement that the product is a compounded medication, has not been approved by the FDA, and has not been evaluated by the FDA for safety or effectiveness.

Multiple states have introduced similar bills aimed at more closely regulating compounding of medications, specifically for GLP-1s. If you would like additional information, to read the language of this bill or to contact the sponsors or committee, you can find the information you need through here: HB 4036.